Embryo Transfer Catheters/Sets

• 2 recalls, same reason

  • Terminated Z-0415-2020 FDA Class II ·initiated 3 Oct 2019
  • Terminated Z-0416-2020 FDA Class II ·initiated 3 Oct 2019

  Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.

• • Terminated Z-1188-2018 FDA Class II ·initiated 19 Dec 2017

  Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.

510(k) Number

K983594 ↗

FDA Product Code

MQF

Device Class

Class II

Regulation

21 CFR Part 884.6110

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Stamey Needle

  Class I

  FDA 510(k) K884553 Active Cleared 14 Nov 1988

• Tubal Lumen Support

  Class II

  FDA 510(k) K932114 Active Cleared 27 Sep 1994

• Sholkoff Balloon Hysterosalpingography Catheter

  Class II

  FDA 510(k) K891290 Active Cleared 23 May 1989

• Bakri Postpartum Balloon, Model J-Sos-100500

  Class II

  FDA 510(k) K062438 Active Cleared 27 Oct 2006

• Balloon Dilation Catheter

  Class II

  FDA 510(k) K896448 Active Cleared 7 Mar 1990

• Laparoscopic Catherter

  Class II

  FDA 510(k) K903187 Active Cleared 12 Oct 1990

See all devices from Cook Ob/Gyn →